Comparing a foam composite to a hydrocellular foam dressing in the management of venous leg ulcers: a controlled clinical study.

Venous leg ulcers are the most prevalent form of chronic wounds in the Western world. The principles of moist wound healing coupled with the use of graduated compression bandaging have become the cornerstone of treatment for venous leg ulcers but not all moist dressings are alike. To compare the attributes of a foam composite dressing with those of a hydrocellular foam dressing in the management of venous leg ulcers, a prospective, randomized, comparative 12-week study was conducted in 15 centers in the US, Canada, France, Germany, and the UK. Dressings were changed and compression bandages applied per manufacturer recommendations and dressing performance was assessed at every dressing change and at the final evaluation. Patients with venous ulcers were randomized to treatment for 12 weeks with either hydrocellular foam (n = 52) or foam composite (n = 55) dressing. Healing differences between the groups were not statistically significant, with 36% of patients using foam composite dressing healed in a mean of 66 days and 39% of patients using hydrocellular foam dressing healed in a mean of 73 days. However, the foam composite dressing performed significantly better than the hydrocellular foam dressing with regard to condition of the periwound skin - 55% of patients in the foam composite group having healed or markedly improved surrounding skin compared to 37% of patients using hydrocellular foam (P = 0.03). The foam composite dressing was rated significantly better than the hydrocellular foam dressing ("very good" to "excellent") in level of satisfaction with conformability (87% and 75%, respectively, P = 0.05); being non-sensitizing (73% and 52%, respectively, P = 0.02); and ease of application (93% and 81%, respectively, P = 0.01). The findings reported in this study suggest that the foam composite dressing offers significant improvements in the quality of life of patients with venous leg ulcers as well as for their caregivers.